FDA Approves Device for Pancreas Care - Summary - MDSpire

FDA Approves Device for Pancreas Care

In the phase 3 PANOVA-3 trial, adding Tumor Treating Fields therapy to gemcitabine and nab-paclitaxel was associated with improved overall survival and delayed pain progression in adults with locally advanced pancreatic cancer.

  • By

  • Kathryn Wighton

  • February 12, 2026

  • 3 min

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Objective:

To evaluate the efficacy and safety of Optune Pax in combination with chemotherapy for patients with locally advanced pancreatic cancer.

Approach:
    Key Findings:
    • Median overall survival was 16 months for Optune Pax plus chemotherapy vs 14 months for chemotherapy alone.
    • In the modified per protocol population, median overall survival was 18 months with Optune Pax vs 15 months with chemotherapy alone.
    • One-year survival rates were 68% in the Optune Pax group vs 60% in the control group.
    • Optune Pax prolonged time to pain progression (15 months vs 9 months).
    • Quality-of-life assessments showed longer deterioration-free survival in multiple health aspects for Optune Pax patients.
    Interpretation:

    Optune Pax represents a significant advancement in the treatment of locally advanced pancreatic cancer, improving survival and quality of life without increasing systemic toxicity.

    Limitations:
    • No significant differences in progression-free survival, local progression-free survival, or tumor resectability were observed.
    • Device-related skin adverse events occurred in 76% of patients, though mostly mild.
    Conclusion:

    Optune Pax is a novel, non-invasive therapy that can be integrated into daily life, expanding cancer care access beyond traditional settings.

    Sources:

Original Source(s)

FDA Approves Device for Pancreas Care

  • by Kathryn Wighton

  • February 12, 2026

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